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Acta bioquímica clínica latinoamericana
versión impresa ISSN 0325-2957
Resumen
UNGER, Gisela et al. Analytical performance evaluation of three methods for hemoglobin A1c quantification. Acta bioquím. clín. latinoam. [online]. 2014, vol.48, n.2, pp.183-189. ISSN 0325-2957.
The laboratory must guarantee the accuracy of HbA1c results meeting the increasingly strict international analytical quality standards and assuring that an HbA1c variation of 0.5 percentage points (%-NGSP) or more between two consecutive controls of a diabetic patient is due to a clinical variation and not to an analytical variation. In this paper, the analytical performance of three commercial methods for HbA1c: Immunoturbidimetric, Chromatographic and Enzymatic Cation Exchange, were evaluated. For this purpose, commercial controls with assigned values traceable to the IFCC reference method for HbA1c were processed. For each methodology, total Coefficient of Variation (CV%), Bias%, Total Error (TE%), Change Reference Value and Clinically Significant Change (CSC) at the critical point of HbA1c 7.0%-NGSP were determined. Within the analytical conditions of this study, only the immunoturbidimetric method had an acceptable analytical performance, allowing attribute a change in 0.5%-NGSP to a significant clinical variation. Faced with international recommendations on the use of HbA1c on control and diagnosis of diabetes, the importance of choosing a method that meets the minimum analytical quality requirements to ensure the clinical utility of HbA1c result is undeniable.
Palabras clave : Hemoglobin A1c; Glycated hemoglobin; Analytical quality requirements; Methodology; Analytical performance; Change reference value; Diabetes diagnosis; Management of the diabetic patient.